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Somatex Medical Technologies GMBH Recall 87317

Description: Thread-like wire marker

Somatex Medical Technologies GMBH Recall 87317 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1200-2021
Event ID87317
Event DescriptionThread-like wire marker
Product TypeDevices
DistributionDomestic: Mo, NJ, OH
Quantity196 pieces
Recall ReasonThis recall has been initiated due to the risk of wire splintering after contact with a cautery device during the removal of a lesion. There is a potential risk that wire fragments are not removed during the procedure and stays inside the patient's body.
Device Classification20210317
Device Code InfoTuflex: REF 271640 Affected Lots: 51268, 51414; REF 271641 Affected Lots: 51269, 51410; REF 271642 Affected Lots: 51270, 51411; REF 271643 Affected Lots: 51271, 51412. Tuflex Premium: REF 271650 Affected Lots: 51300; REF 271651 Affected Lots: 51299, 51413; REF 271652 Affected Lots: 51301.
Center Classification Date20210310
Recall Initiation Date20210203
Recalling FirmSomatex Medical Technologies GMBH
Initial Notification E-Mail
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